Systemic Lupus Erythematosus Market to Exhibit Growth at a CAGR of 9.4% During the Forecast Period (2025–2034) Owing to Rising Use of Biologics – Approvals of BENLYSTA and SAPHNELO, Plus a Strong Pipeline | DelveInsight
The total market size of systemic lupus erythematosus is expected to increase in the 7MM during the forecast period, driven by ongoing clinical research of therapies such as nipocalimab (Johnson & Johnson), Litifilimab (Biogen and Royalty Pharma), Ianalumab (Novartis), Cenerimod (Idorsia and Viatris), Rapcabtagene autoleucel (YTB323) (Novartis), KK-4277 (Kyowa Kirin), and others, and better diagnostic tools, which might improve the prognosis of the disease.
New York, USA, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Systemic Lupus Erythematosus Market to Exhibit Growth at a CAGR of 9.4% During the Forecast Period (2025–2034) Owing to Rising Use of Biologics – Approvals of BENLYSTA and SAPHNELO, Plus a Strong Pipeline | DelveInsight
The total market size of systemic lupus erythematosus is expected to increase in the 7MM during the forecast period, driven by ongoing clinical research of therapies such as nipocalimab (Johnson & Johnson), Litifilimab (Biogen and Royalty Pharma), Ianalumab (Novartis), Cenerimod (Idorsia and Viatris), Rapcabtagene autoleucel (YTB323) (Novartis), KK-4277 (Kyowa Kirin), and others, and better diagnostic tools, which might improve the prognosis of the disease.
DelveInsight’s Systemic Lupus Erythematosus Market Insights report includes a comprehensive understanding of current treatment practices, emerging systemic lupus erythematosus drugs, market share of individual therapies, and current and forecasted systemic lupus erythematosus market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).
Systemic Lupus Erythematosus Market Summary
- 2024 US Systemic Lupus Erythematosus Market Size: USD 2.8 Billion
- Systemic Lupus Erythematosus Market Growth Rate (2025-2034): 9.4%
- Largest Systemic Lupus Erythematosus Market: United States
- 2024 US Diagnosed Systemic Lupus Erythematosus Prevalent Cases: 529K
- FDA-Approved Systemic Lupus Erythematosus Drugs: BENLYSTA (GlaxoSmithKline) and SAPHNELO (AstraZeneca)
- Key Systemic Lupus Erythematosus Companies Developing Drugs: Johnson & Johnson, Biogen, Royalty Pharma, Novartis, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Bristol Myers Squibb, AbbVie, and others.
- Key Systemic Lupus Erythematosus Therapies in Clinical Trials: Nipocalimab, Litifilimab, Ianalumab (VAY736), Cenerimod, Telitacicept (RC18), Dapirolizumab pegol, SOTYKTU (deucravacitinib), RINVOQ (upadacitinib), and others.
Discover SLE market CAGR and projections to 2034 @ Systemic Lupus Erythematosus Market Report
Sadaf Javed, Manager of Forecasting and Analytics at DelveInsight, commented: “The systemic lupus erythematosus market is poised for significant growth over the coming decade, driven by a combination of rising disease prevalence, increased diagnostic awareness, and a robust pipeline of targeted therapies. Additionally, supportive regulatory environments and greater investment in autoimmune disease research are catalyzing market entry of innovative products. These factors collectively suggest that the SLE market will not only grow in terms of revenue but also evolve qualitatively, with more personalized and effective treatment paradigms transforming patient care.”
Key Factors Driving the Growth of the Systemic Lupus Erythematosus Market
- Rising SLE Prevalence: As per DelveInsight's analysis, in 2024, the US accounted for approximately 529K diagnosed prevalent cases of SLE. These are expected to increase during the forecast period (2025−2034).
- Currently FDA-Approved Therapies for SLE: At present, the SLE treatment landscape includes just two FDA-approved therapies: BENLYSTA (GSK) and SAPHNELO (AstraZeneca).
- Promising Drug Classes in Development: The presence of a robust pipeline with promising assets, including JAK inhibitors, targeted antibodies, and tyrosine kinase inhibitors, offers a potential curative avenue for patients.
- Launch of Emerging SLE Drugs: The SLE pipeline includes several therapies in mid- to late-stage development that are expected to receive approval in the near term. The evolving treatment landscape features a broad array of therapeutic options, such as nipocalimab (Johnson & Johnson), litifilimab (Biogen and Royalty Pharma), ianalumab (Novartis), cenerimod (Idorsia and Viatris), rapcabtagene autoleucel (YTB323) (Novartis), KK-4277 (Kyowa Kirin), and other agents across multiple lines of therapy. The anticipated launch of these products is expected to influence market growth positively.
Systemic Lupus Erythematosus Market Analysis
- There is currently no curative therapy for systemic lupus erythematosus; treatment is focused on disease control rather than cure.
- Therapeutic goals include controlling disease activity, achieving and sustaining remission, improving long-term outcomes, minimizing cumulative organ damage, and enhancing patients’ quality of life.
- To date, only two therapies have received FDA approval for SLE: BENLYSTA (belimumab) from GlaxoSmithKline and SAPHNELO (anifrolumab) from AstraZeneca.
- Despite these approvals, clinicians continue to report a substantial unmet need for therapies with greater efficacy and improved safety profiles.
- Many patients cycle through multiple lines of treatment over the course of the disease, highlighting the limitations of current options, which primarily focus on symptom control and disease maintenance.
- Symptom-directed management typically includes NSAIDs, antimalarials, glucocorticoids, and other immunosuppressive agents.
- Glucocorticoids remain a cornerstone of SLE therapy; however, concerns regarding long-term toxicity have made steroid-sparing strategies and dose minimization key objectives in treat-to-target approaches.
- Several emerging biologic and targeted therapies, such as litifilimab, ianalumab, and deucravacitinib, are expected to expand and reshape the SLE treatment landscape in the coming years.
Learn more about which therapies will shape the future SLE market @ Systemic Lupus Erythematosus Treatment Market
Systemic Lupus Erythematosus Competitive Landscape
SLE clinical trial landscape possesses some drugs in mid- and late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including nipocalimab (Johnson & Johnson), Litifilimab (Biogen and Royalty Pharma), Ianalumab (Novartis), Cenerimod (Idorsia and Viatris), Rapcabtagene autoleucel (YTB323) (Novartis), KK-4277 (Kyowa Kirin), and others in different lines of treatment.
Johnson & Johnson’s Nipocalimab is an investigational monoclonal antibody engineered to selectively and strongly inhibit FcRn, thereby reducing circulating immunoglobulin G (IgG) antibodies while having minimal impact on other innate and adaptive immune functions. By lowering pathogenic autoantibodies and alloantibodies, nipocalimab has potential applications across key autoantibody-driven areas, including rare autoimmune disorders, maternal–fetal diseases caused by maternal alloantibodies, and rheumatic diseases mediated by autoantibodies. In the placenta, FcRn inhibition is also expected to reduce the transfer of maternal alloantibodies to the fetus.
Biogen and Royalty Pharma’s Litifilimab (BIIB059) is a humanized IgG1 monoclonal antibody directed against BDCA2 and is under investigation as a potential therapy for systemic lupus erythematosus (SLE). BDCA2 is a receptor selectively expressed on plasmacytoid dendritic cells (pDCs), a specialized subset of immune cells. By binding to BDCA2, litifilimab suppresses pDC activity, leading to reduced secretion of pro-inflammatory mediators, including type I interferons (IFN-I) and other cytokines and chemokines. Biogen is currently evaluating litifilimab in two Phase III clinical studies for SLE, TOPAZ-1 (NCT04895241) and TOPAZ-2 (NCT04961567), with topline results anticipated by the end of 2026.
Novartis’ Ianalumab is a monoclonal antibody targeting the B-cell activating factor receptor (BAFF-R). The therapy is designed to inhibit BAFF-R–dependent signaling pathways while also inducing B-cell depletion via antibody-dependent cellular cytotoxicity. Ianalumab is being assessed in Phase III trials for SLE, including SIRIUS-SLE 1 (NCT05639114) and SIRIUS-SLE 2 (NCT05624749). According to Novartis’ Q3 2025 update, Phase III data are expected in 2027, with regulatory filings now anticipated in 2028 or later.
Idorsia and Viatris’ Cenerimod is a highly selective sphingosine-1-phosphate receptor 1 (S1P1) modulator administered as a once-daily oral therapy. Although the precise etiology of SLE remains unclear, dysregulated T- and B-cell activity is recognized as a central contributor to disease pathogenesis. Cenerimod is currently being evaluated in Phase III trials, OPUS-1 (NCT05648500) and OPUS-2 (NCT05672576), for the treatment of SLE. The U.S. FDA has granted Fast Track Designation to cenerimod for this indication.
Aparna Thakur, Assistant Project Manager, Forecasting and Analytics at DelveInsight, commented: “The systemic lupus erythematosus clinical trial landscape is increasingly robust, with several mid- to late-stage assets positioning the market for meaningful evolution over the next few years. Nipocalimab’s FcRn inhibition strategy aims to selectively reduce pathogenic IgG autoantibodies, while litifilimab targets plasmacytoid dendritic cell–driven type I interferon signaling, with Phase III readouts expected by late 2026. The anticipated launches of these next-generation therapies are expected to significantly reshape the SLE treatment paradigm, intensifying competition, redefining standards of care, and driving sustained innovation and market expansion in the years ahead.”
The anticipated launch of these emerging SLE therapies are poised to transform the SLE market landscape in the coming years. As these cutting-edge SLE therapies continue to mature and gain regulatory approval, they are expected to reshape the SLE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about new treatment for SLE, visit @ Systemic Lupus Erythematosus Medication
Recent Developments in the SLE Market
- In January 2026, Johnson & Johnson reported favorable topline findings from the Phase 2b JASMINE (NCT04882878) trial in adults with systemic lupus erythematosus (SLE) and announced the launch of a Phase 3 development program.
- In January 2026, the Phase III TULIP-SC data demonstrated that subcutaneous administration of SAPHNELO (anifrolumab) led to a statistically significant and clinically meaningful improvement in disease activity compared with placebo in patients with systemic lupus erythematosus (SLE). The findings were published in Arthritis & Rheumatology.
- In May 2025, AbelZeta Pharma announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational cell-based therapy C-CAR168 for refractory Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).
- In February 2025, Biogen entered into an arrangement with Royalty Pharma under which Biogen will receive up to USD 200 million in 2025 and up to USD 50 million in 2026 to co-fund the development costs for the litifilimab program.
- In February 2025, Idorsia Pharmaceuticals revised its collaboration with Viatris for cenerimod, reducing its 2025 development cost contribution by USD 100 million. In return, Idorsia agreed to a USD 250 million cut in future regulatory and sales milestone payments, while also expanding Viatris’ territorial rights for the drug.
What is Systemic Lupus Erythematosus?
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the body’s immune system mistakenly attacks its own healthy tissues, leading to widespread inflammation and organ damage. It can affect multiple organs and systems, including the skin, joints, kidneys, heart, lungs, blood cells, and nervous system. The disease is characterized by periods of flare-ups and remission, with symptoms varying widely among individuals. Common manifestations include fatigue, joint pain and swelling, skin rashes, fever, and kidney involvement. While the exact cause of SLE is unknown, it is believed to result from a combination of genetic, hormonal, and environmental factors, and it requires long-term management to control symptoms and prevent organ damage.
Systemic Lupus Erythematosus Epidemiology Segmentation
The SLE epidemiology section provides insights into the historical and current systemic lupus erythematosus patient pool and forecasted trends for the leading markets. As per the estimates, in the US, approximately half of the patients suffering from SLE were in moderate severity at the time of diagnosis.
The systemic lupus erythematosus market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:
- Total Diagnosed Prevalent Cases of SLE
- Total Diagnosed Prevalent Cases of SLE by Age
- Total Diagnosed Prevalent Cases of SLE by Gender
- Severity-specific Diagnosed Prevalent Cases of SLE
- Total Treated Cases of SLE by Line of Therapy
Download the report to understand current treatment standards influencing market share @ Systemic Lupus Erythematosus Treatment Options
| Systemic Lupus Erythematosus Market Report Metrics | Details |
| Study Period | 2020–2034 |
| Systemic Lupus Erythematosus Market Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Systemic Lupus Erythematosus Market CAGR | 9.4% |
| Systemic Lupus Erythematosus Market Size (US) | USD 2.8 Billion |
| Key Systemic Lupus Erythematosus Companies | Johnson & Johnson, Biogen, Royalty Pharma, Novartis, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Bristol Myers Squibb, AbbVie, GlaxoSmithKline, AstraZeneca, and others |
| Key Systemic Lupus Erythematosus Therapies | Nipocalimab, Litifilimab, Ianalumab (VAY736), Cenerimod, Telitacicept (RC18), Dapirolizumab pegol, SOTYKTU (deucravacitinib), RINVOQ (upadacitinib), BENLYSTA, SAPHNELO, and others |
Scope of the Systemic Lupus Erythematosus Market Report
- Systemic Lupus Erythematosus Therapeutic Assessment: Systemic Lupus Erythematosus current marketed and emerging therapies
- Systemic Lupus Erythematosus Market Dynamics: Conjoint Analysis of Emerging Systemic Lupus Erythematosus Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Systemic Lupus Erythematosus Market Unmet Needs, KOL’s views, Analyst’s views, Systemic Lupus Erythematosus Market Access and Reimbursement
Discover more about SLE drugs in development @ Systemic Lupus Erythematosus Clinical Trials
Table of Contents
| 1 | Systemic Lupus Erythematosus Market Key Insights |
| 2 | Systemic Lupus Erythematosus Market Report Introduction |
| 3 | Executive Summary of SLE |
| 4 | Key Events |
| 5 | Epidemiology and Market Forecast Methodology |
| 6 | SLE Market Overview at a Glance |
| 6.1 | Emerging Therapies Analysis (By Phase, RoA, and Molecule Type) |
| 6.2 | Market Share (%) Distribution of SLE by Therapies in 2025 |
| 6.3 | Market Share (%) Distribution of SLE by Therapies in 2034 |
| 7 | Disease Background and Overview |
| 7.1 | Introduction |
| 7.2 | SLE Causes and Risk Factors |
| 7.3 | SLE Signs and Symptoms |
| 7.4 | SLE Pathophysiology |
| 7.5 | SLE Diagnosis |
| 7.6 | SLE Treatment |
| 8 | Epidemiology and Patient Population in the 7MM |
| 8.1 | Key Findings |
| 8.2 | Assumptions and Rational |
| 8.3 | Total Diagnosed Prevalent Cases of SLE in the 7MM |
| 8.4 | The United States |
| 8.4.1 | Total Diagnosed Prevalent Cases of SLE in the United States |
| 8.4.2 | Total Diagnosed Prevalent Cases of SLE by Gender in the United States |
| 8.4.3 | Total Diagnosed Prevalent Cases of SLE by Age in the United States |
| 8.4.4 | Severity-specific Diagnosed Prevalent Cases of SLE in the United States |
| 8.4.5 | Total Treated Cases of SLE in the United States |
| 8.5 | EU4 and the UK |
| 8.6 | Japan |
| 9 | SLE Patient Journey |
| 10 | Marketed SLE Therapies |
| 10.1 | Marketed Key Cross |
| 10.2 | BENLYSTA (belimumab): GlaxoSmithKline |
| 10.2.1 | Product Description |
| 10.2.2 | Regulatory Milestone |
| 10.2.3 | Other Developmental Activities |
| 10.2.4 | Summary of Pivotal Clinical Trial |
| 10.2.5 | Clinical Development |
| 10.2.5.1 | Clinical Trial Information |
| 10.2.6 | Safety and Efficacy of Ongoing Trials |
| 10.2.7 | Analyst Views |
| 10.3 | SAPHNELO (anifrolumab): AstraZeneca |
| 11 | Emerging SLE Therapies |
| 11.1 | Key Cross Competition |
| 11.2 | Litifilimab: Biogen and Royalty Pharma |
| 11.2.1 | Product Description |
| 11.2.2 | Other Developmental Activities |
| 11.2.3 | Clinical Development |
| 11.2.3.1 | Clinical Trial Information |
| 11.2.4 | Safety and Efficacy |
| 11.2.5 | Analyst Views |
| 11.3 | Ianalumab (VAY736): Novartis |
| 11.4 | Cenerimod: Idorsia Pharmaceuticals and Viatris |
| 11.5 | Telitacicept (RC18): RemeGen |
| 11.6 | Dapirolizumab pegol: UCB Pharma/Biogen |
| 11.7 | SOTYKTU (deucravacitinib): Bristol Myers Squibb |
| 11.8 | RINVOQ (upadacitinib): AbbVie |
| List to be continued in the report… | |
| 12 | SLE Market: The 7MM Analysis |
| 12.1 | Key Findings |
| 12.2 | Systemic Lupus Erythematosus Market Outlook |
| 12.3 | Conjoint Analysis |
| 12.4 | Key Systemic Lupus Erythematosus Market Forecast Assumptions |
| 12.5 | Total Market Size of SLE in the 7MM |
| 12.6 | The United States Systemic Lupus Erythematosus Market Size |
| 12.6.1 | Total Market Size of SLE in the United States |
| 12.6.2 | Market Size of SLE by Therapies in the United States |
| 12.7 | EU4 and the UK Systemic Lupus Erythematosus Market Size |
| 12.8 | Japan Systemic Lupus Erythematosus Market Size |
| 13 | Systemic Lupus Erythematosus Market Unmet Needs |
| 14 | Systemic Lupus Erythematosus Market SWOT Analysis |
| 15 | KOL Views on SLE |
| 16 | Systemic Lupus Erythematosus Market Access and Reimbursement |
| 16.1 | United States |
| 16.2 | EU4 and the UK |
| 16.3 | Japan |
| 16.4 | Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
| 16.5 | Market Access and Reimbursement of SLE |
| 17 | Bibliography |
| 18 | Systemic Lupus Erythematosus Market Report Methodology |
Related Reports
Systemic Lupus Erythematosus Epidemiology Forecast
Systemic Lupus Erythematosus Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted SLE epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Systemic Lupus Erythematosus Clinical Trial Analysis
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